Brief Summary

The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is effective in treating painful HIV-associated neuropathy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

300

participants targeted

Target at P25-P50 for phase_3 hiv-infections

Timeline

Completed

Started Aug 2003

Shorter than P25 for phase_3 hiv-infections

Geographic Reach

1 country

35 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

First Submitted

Initial submission to the registry

July 10, 2003

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2003

Completed

21 days until next milestone

Study Start

First participant enrolled

August 1, 2003

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed

Last Updated

March 6, 2008

Status Verified

March 1, 2008

First QC Date

July 10, 2003

Last Update Submit

March 4, 2008

Conditions

HIV Infections Peripheral Nervous System Diseases Pain

Keywords

Dermal assessmentPain measurementDiaryAnalgesics/*therapeutic useCapsaicin/*administration & dosage/adverse effectsHIV Infections/*complications/*drug therapyPeripheral Nervous System Diseases/*complications/diagnosis/*therapyPeripheral Nervous System Diseases/drug therapy/*etiology/physiopathology

Outcome Measures

Primary Outcomes (1)

Percent change from baseline in the "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2-12, compared to baseline)

Secondary Outcomes (7)

Percent change from baseline in the "average pain for the past 24 hours" NPRS score (i.e., average of scores during Weeks 2-4 and 2-8, respectively, compared to baseline)
Proportion of subjects reaching 30% decrease from baseline in their "average pain for the past 24 hours" NPRS scores on average during Weeks 2-12, within each treatment group
Proportion of subjects reaching 30% decrease from baseline in their "average pain for the past 24 hours" NPRS scores on average during Weeks 2-4 and 2 8, respectively, within each treatment group
Percent change from baseline in the "worst pain for the past 24 hours" and "pain now" NPRS scores (baseline score compared to the average of scores from Weeks 2 -12), within each treatment group
"Pain now" on evening of treatment day
+2 more secondary outcomes

Interventions

Capsaicin Dermal PatchDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

At least 18 years of age
Documented evidence of HIV-1 infection
Documented diagnosis of painful HIV-associated distal symmetrical polyneuropathy established by a neurologist resulting from HIV disease and/or antiretroviral drug exposure, with primary symptoms of pain, burning or dysesthetic discomfort in both feet for at least 2 months prior to Screening Visit, and absent or diminished ankle reflexes, and at least one of the following: distal diminution of vibration sensation or pain or temperature sensation in the legs
Either no neurotoxic antiretroviral (didanosine, zalcitabine or stavudine) exposure for at least 8 weeks prior to Screening Visit, or currently on stable dose(s) of any neurotoxic antiretroviral(s) for at least 8 weeks prior to Screening Visit
Screening Pain Sum Score of 12 to 36
Karnofsky Performance Score of greater than or equal to 60
Intact, unbroken skin over the painful area(s) to be treated
If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21 days prior to Treatment Visit and willing to maintain these medications at the same stable dose(s) and schedule throughout the study
Female subjects with child-bearing potential: negative serum pregnancy test performed at Screening Visit
Willing to use effective methods of birth control and/or refrain from participating in a conception process during study and for 30 days following experimental drug exposure
Willing and able to comply with protocol requirements for duration of study

You may not qualify if:

Concomitant opioid medication, unless orally or transdermally administered and not exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose
Unavailability of an effective rescue medication strategy for the subject, such as unwillingness to use opioid analgesics during treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with Roxicodone® or Vicodin®, as judged by the Investigator
Active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely to recur during the study period by the investigator
Recent use (within 21 days preceding the Treatment Visit of any topically applied pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas
Current use of any investigational agent or Class 1 anti-arrhythmic drugs
Significant pain of an etiology other than painful HIV-associated neuropathy; significant ongoing pain from other cause(s) that may interfere with judging HIV-associated neuropathy pain
Evidence of another contributing cause for peripheral neuropathy, e.g., diabetes mellitus requiring medication control (i.e., oral hypoglycemics, insulin); hereditary neuropathy; vitamin B12 deficiency (B12 level ≤ 200 pg/mL) or less than 3 months of B12 supplementation prior to Screening Visit; or treatment within 90 days prior to Screening Visit with any drug that may have contributed to the sensory neuropathy
Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain
Treatment for acute opportunistic infections within 14 days before Treatment Visit
Presence of acute, active opportunistic infection, except oral thrush; oral, genital, or rectal herpes; and Mycobacterium avium bacteremia within 2 weeks prior to Screening Visit
Currently have active malignant disease
Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events
Hypersensitivity to capsaicin (i.e., chili peppers or OTC capsaicin products), local anesthetics, Roxicodone®, Vicodin®, or adhesives

Contact the study team to confirm eligibility.